Filtration system for preparation of fluids for medical applications

ABSTRACT

A fluid preparation system has a sealed sterilized fluid circuit with a sealed sterilized container with a conductivity sensor in communication with an interior of said container. Further, at least one sealed connector is adapted for adding fluid to said container, and at least one sealed connector is adapted for removing fluid from said container. The conductivity sensor is contained in a test line in communication with said interior and is adapted to be connected to a source of suction thereby to draw a sample of contents of said container. Furthermore, the test line may have a check valve to prevent ingress of contaminants into said container, and the sealed connector is adapted for adding fluid to said container and may have an inline sterile filter. Furthermore, the system may have a controller that controls pumping actuators.

RELATED APPLICATIONS

The present application is a continuation of U.S. application Ser. No.15/615,655 filed Jun. 6, 2017, which is a continuation of U.S.application Ser. No. 11/813,472, filed May 12, 2008, which issued asU.S. Pat. No. 9,700,663 on Jul. 11, 2017, which is a national stageentry of International Application No. PCT/US06/00608, filed Jan. 9,2006, which claims foreign priority to PCT/US05/00381, filed Jan. 7,2005, all of which applications are incorporated herein by reference intheir entireties.

BACKGROUND OF THE INVENTION

Many medical applications require purified water and other fluids, forexample, hemofiltration, tissue irrigation, and hemodiafiltration. Someprior art systems have focused on continuous purification processes thatrequire a separate diafiltration/purification apparatus that must beperiodically purged and verified to provide sufficient constant flow ofsterile replacement fluid. (See Chavallet U.S. Pat. Nos. 6,039,877 and5,702,597.) Such devices are necessarily complicated and requireseparate pumping systems for the purification process. In addition, therate of supply of fluid for such systems is very high, requiringexpensive filters to be used. The same high-rate problem exists for thegeneration of replacement fluid for hemofiltration, and therefore alsorequires expensive filtering apparatus.

Large and small scale inline systems are known for preparation ofinfusible fluids and for preparation of dialysate. The following priorart references discuss examples of such systems. US Patent PublicationNo. 2004/0232079 US Patent Publication No. 2003/0105435; U.S. Pat. Nos.5,645,734 5,782,762 6,136,201; PURELAB Maxima, Ultra-Pure WaterPurification Systems (http://www.elqalabwater.com); Shipe, Brad; “TheCase for UV in Dechlorination Applications,” Water Conditioning &Purification Magazine, January 2003, Vol 45 No. 1.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A shows schematically at a high level a water purification systemaccording to embodiments of the disclosed subject matter.

FIG. 1 B illustrates a filter device with control elements that provideassurance of fluid quality and prevent breakthrough of contaminationupon filter expiration.

FIGS. 2A and 2B illustrate a filter and batch container with connectorsystems that ensure against contamination.

FIG. 3 illustrates a self-clamping connector.

FIG. 4 illustrates a batch container tubing set.

FIG. 5 illustrates a fluid preparation apparatus embodiment in afigurative way for discussing various features and arrangements of awater purification system.

FIGS. 6, 7, and 8A illustrate portions of an embodiment of a fluidpreparation apparatus.

FIG. 8B illustrates a portion of a filter module in which two redundantultrafiltration membranes are commonly housed.

FIGS. 9A and 9B illustrate embodiments of a batch container.

FIG. 10A illustrates a fluid quality sensor such as a conductivity orresistivity sensor configuration for sensing fluid quality in acontainer.

FIG. 10B illustrates a medicament concentrate cartridge.

FIG. 11 illustrates a filter module in partial ghost perspective view.

FIG. 12 illustrates a filter cartridge with an expansion device.

FIGS. 13A and 13B illustrate fluid preparation devices for use with areplaceable filter module such as the one illustrated in FIG. 11.

FIG. 14 illustrates a control system to support features of variousembodiments.

FIG. 15 is a flow chart for discussing various control options of thevarious embodiments discussed herein.

FIG. 16 illustrates a treatment environment for use of a controlembodiment.

FIGS. 17, 17A, and 18 illustrate ultrafilter configurations that aretolerant of the evolution of air from within the ultrafilter.

FIG. 19A is a flow diagram of a treatment fluid preparation and storagedevice according to an embodiment of the invention.

FIGS. 19B through 19H and 19J illustrate operating modes of a flowcircuit component and control component of a treatment fluid preparationand storage device according to an embodiment of the invention.

FIGS. 20A and 20B are flow charts illustrating operations of a treatmentfluid preparation and storage device according to an embodiment of theinvention.

FIGS. 21A to 21C illustrate details of the operation of FIGS. 20A and20B.

FIG. 22 is a circuit diagram illustrating features of a treatment fluidpreparation and storage device according to an embodiment of theinvention.

FIG. 23 is a diagram of a flow director.

FIGS. 24 and 25 illustrate various mechanical features including ahousing for a treatment fluid preparation and storage device accordingto an embodiment of the invention.

FIG. 26 illustrates a long term disposable filter module for a treatmentfluid preparation and storage device according to an embodiment of theinvention.

FIG. 27 is a circuit diagram illustrating features of a treatment fluidpreparation and storage device according to an embodiment of theinvention.

FIG. 28 is a diagram of a compact peritoneal dialysis cycler.

SUMMARY OF SOME EMBODIMENTS

According to an embodiment, the inventions include a medical fluidtreatment device, comprising: a housing having water supply and drainconnections and an electrical supply connection, a treatment fluidpreparation device configured to purify water, and use the purifiedwater to dilute a solute to prepare a batch of a purified water, thebatch being contained in a disposable container enclosed in the housing,the batch containing enough treatment fluid to perform multiple renalreplacement therapy treatments each being at least a day apart, a heaterconfigured to maintain a temperature of the batch at a temperature forimmediate use in renal replacement therapy, a controller configured toindicate at least one of: an indication that the batch has expired, isabout to expire, an amount of time before the batch will expire, thecontroller being configured to make the batch available for multipletreatments, and connections for connecting a renal replacement therapydevice to receive contents of the batch.

According to another embodiment, the device is such that the disposablecontainer is a bag and the housing has a tank portion configured tosupport the bag.

According to another embodiment, the device is such that the bagincludes a first filter that is replaced each time the bag is replaced.

According to another embodiment, the device is such that the housing hasa table top surface and the table top is configured to support the renalreplacement therapy device.

According to another embodiment, the device is such that the housing hasa table top surface and a height not greater than 1 m.

According to another embodiment, the device is such that the treatmentfluid preparation device includes a disposable filtration module that isreplaced one every multiple batches.

According to another embodiment, the device is such that the disposablecontainer is a bag and the housing has a tank portion configured tosupport the bag, the tank portion being configured as a drawer portionthat is hidden behind a door on front of the housing. According toanother embodiment, the device is such that the housing has a table topsurface and a height not greater than 1 m., the table top isuninterrupted by any fixtures, the controller has a user interfacemounted on a front of the housing.

According to another embodiment, the device is such that the housing hasa table top surface and a height not greater than 75 cm.

According to another embodiment, the device is such that the disposablecontainer has multiple outlet connections, each configured with anon-reopenable clamp.

According to another embodiment, the device is such that the treatmentfluid includes a lactate based dialysate.

According to another embodiment, the device is such that the housing isfitted with wheels.

According to another embodiment, the device is such that the disposablecontainer is a bag and the housing has a recess portion configured tosupport the bag, the recess having a bottom on which the bag sits, thebottom being at a bottom of the housing and having at least one leaksensor therein.

According to another embodiment, the device is such that the housing hasat least one leak sensor outside of any fluid containing or conveyingcomponent to detect leaks.

According to another embodiment, the device is such that the controlleris configured to empty the batch after use.

According to another embodiment, the device is such that the drainconnection includes a Y-junction receiving a connection from thedisposable container and a connector for connection to a spent fluidline of the treatment machine.

According to another embodiment, the device is such that one leg of theY-junction includes a conductivity sensor configured to allow thecontroller to test a sample of the batch by flushing a portion thereofinto the Y-junction.

According to another embodiment, the device is such that the disposablecontainer includes an actuator portion with a filter that is replacedfor each batch.

According to another embodiment, the device is such that the treatmentfluid preparation device includes a filter that is replaced once everymultiple batches.

According to another embodiment, the device further comprises a pump andfluid circuit portion configured to generate a constant pressure foruptake by the treatment device.

According to another embodiment, the device is such that the fluidcircuit portion is a feedback loop that returns to the disposablecontainer and includes an inline check valve with a cracking pressureequal to the constant pressure.

According to another embodiment, the device includes a valve actuatorassembly configured to draw concentrate from a container and supply theconcentrate to the disposable container, to rinse the concentratecontainer and supply a diluted fluid that results from rinsing theconcentrate container to the disposable container.

DETAILED DESCRIPTION

The present disclosure relates to apparatus, methods, devices, articlesof manufacture, etc. for producing pure water and, in some embodiments,pure solutions. These may be used for the preparation of solutions formedical applications such as tissue irrigation, preparation ofpharmaceutical, blood treatments such as hemofiltration, hemodialysis,hemodiafiltration and ultrafiltration, and other treatments.

As described in FIG. 1A, to supply suitable water that is substantiallyfree of unwanted dissolved and undissolved materials, a combination ofpermanent and replaceable components may be provided at the treatmentsite. FIG. 1A is an overview of a framework that provides benefits,particularly in certain environments. One such environment is renalreplacement therapy. Patients must be treated at least twice a week andoften daily. On the other hand, excellent sterility design urges the useof pre-sterilized throw-away components to ensure against various modesof contamination which need not be enumerated. But replacing everycomponent that must be contamination-free upon every use is profoundlyexpensive, particularly where treatments are done every day. Prior artapproaches have addressed this problem by combining permanent componentswhose sterility is guaranteed by intensive sterilization procedures,some of which are backed up (made failsafe) by using additionaldisposable components that are used once and discarded. Alternatively,the disposable can be made more robust to avoid the on-sitesterilization procedures. But this presents the problem of forcing thedesigner to use inexpensive, and therefore less desirable components inthe disposable portions, or of simply imposing the burden of high coston the medical treatment system.

FIG. 1A shows a new model that compromises on this point and isconsidered particularly applicable in the renal replacement therapyenvironment. A permanent module 920 has certain pretreatment componentsthat may be used repeatedly without replacement and withoutsterilization and includes filtration and treatment steps that are notunduly inclined to aggravate, or susceptible to, contamination. Examplesare illustrated in the further embodiments. This permanent module may bedesigned to receive variations of water quality. A semi-permanent module922 provides more than one use, for example a month's worth of uses, butis disposable periodically or upon detection of incipient failure. Thepermanent module may contain a controller to enforce the proper use andhandling of the semi-permanent module since safeguards must be enforcedwith regard to it. But with the semi-permanent modules, as discussedbelow in connection with particular embodiments, the procedures do notinvolve washing, cleansing, sterilization. The final stage includesfinal filtration and/or treatment steps provided in a single-use element924. In the final stage, the least expensive components may be arrangedto guard against sterility failures of the upstream components. As willbe seen, the preferred embodiments described herein conform to thismodel. Variations of the model are possible including fragmenting theintermediate modules into ones used according to other schedules such asone module replaced monthly and another replaced weekly. An example of asemi-permanent element and a control system to safeguard againstcontamination are shown in FIG. 1B. Note that the embodiment of FIG. 1Bmay constitute an independent invention and need not be employed in acombination as discussed with reference to FIG. 1A, although thisidentified as a preferred configuration. Referring to FIG. 1B, a pump416 feeds raw water into a filter module 425 via an input line 403. Thefilter module 425 contains first and second filters 410A and 410B. In anembodiment, the first and second filter stages 410A and 410B aredeionizing filters. The first and second filter stages 410A and 410B maybe accompanied by other types of filters (not shown here but discussedand illustrated elsewhere in the instant specification) in the filtermodule or externally thereto to perform a complete water treatment.Treated water is supplied to a batch container 417, which may or may notbe present. In the illustrated configuration, water is treated forpreparation of a medicament which may be included in concentrate form inthe batch container 417 as a presterilized consumable unit.

Between the first and second filter stages 410A and 410B, a waterquality sensor 405 is provided. In an embodiment, the water qualitysensor 405 is a conductivity or resistivity probe that detects ionicspecies in the water after passing through the first stage filter 410A.In a preferred embodiment, the second stage 410B provides at least someredundancy in that the second stage 410B provides some of the filtrationeffect of the first stage 410A. In an alternative embodiment it providesall of the filtration of the first stage 410A and is thereby completelyredundant. In such an arrangement, the first stage would expire (becomedepleted), allowing contaminants to break through, before the secondstage expires. The contaminant breakthrough is detected by a controller415 connected to the water quality sensor 405. The controller 415 alsocontrols the pump 416. Upon expiration of the first stage 410A, thecontroller allows the preparation to continue until a certain amount offluid is collected in batch container 417, preferably an amount requiredfor a treatment. Once this threshold quantity is delivered, thecontroller will not allow the pump 416 to be started until the filtermodule 425 is exchanged with a fresh one. The second stage filter 410B,preferably, is sized to ensure that, by itself, it can purify at least asingle batch of water, plus a safety margin without any contaminantbreakthrough to the output line 404. In a preferred embodiment, thesecond stage filter 410B is a smaller size than the first 410A. In thepreferred embodiment, the second stage filter 410B may be of a differenttype which may not be as able to handle high contamination loads as thefirst 410A. This may be acceptable because, although after breakthroughis detected, the emerging fluid is still substantially purified and theload input to the second stage filter 410B may remain low until a singlebatch of fluid is prepared.

In an alternative embodiment, the filter module 425 is provided with apermanently attached data carrier 423 such as radio frequencyidentification device (RFID), bar code (1- or 2-dimensional),contact-type identification device, etc. The data carrier 423 contains aunique identifier of the filter module. When a cartridge is connected tothe pump, the controller 415 reads the data carrier 423 using a readerdevice 422 and stores the identifier in a memory 437. If the waterquality sensor 405 indicates contaminant breakthrough, the controllerpermanently stores the identifier in an expired directory in the memory,which has a non-volatile portion for the directory. If a user attemptsto connect a module 425 with an identifier stored in the directory, thecontroller will not operate the pump and will indicate the errorcondition by means of an annunciator 420 or equivalent device, such asan LCD display message.

Note that in an alternative device, the data carrier 423 is aprogrammable device with a writable memory. In this embodiment, thecontroller 415 programs the data carrier 423 with a flag indicating thatthe filter module 425 is expired. The controller 415 then prevents theinitiation of a new batch.

FIG. 1 B also illustrates an optional embodiment with a pressuretransducer 435 that may be used to test for clogging of the first stagefilter 410A. When the pump 416 head pressure reaches a particularmaximum, in order to allow a batch preparation to be completed, thecontroller activates a normally-closed valve 426 to bypass the firstfilter stage 410A. Water flows through a bypass line 427 and through thesecond stage filter 410B. The expiration of the filter module 425 maythen be enforced by the controller in either of the ways describedabove. The above embodiment may be used in filter modules 425 thatcontain filters that clog when depleted such as carbon filters or porousmembrane filters. Not that the clogging and breakthrough devicesdescribed above may be combined or used exclusively in a given filtermodule embodiment. Note also that the head pressure may be sampled andstored over a period of time to determine if the pressure change profileis characteristic of a filter suffering normal usage. This woulddistinguish, for example, an accidental line blockage and preventinappropriate use of the bypass line 427.

Referring to FIGS. 2A and 2B, a multi-use filter device 440 has anoutlet port 441A with a cap 444A to avoid contamination. The outlet port441A is connectable to a mating port 441 B, which is also capped (cap444B). The ports 441 A and 441 B may be, for example, locking luerconnectors. A special clamping connector 442, which seals itself whendisconnected from a mating connector 452 is connected to port 441 B anda line connecting it to a batch container 450 which receives purifiedwater from the multi-use filter device 440. A microporous filter 453guards against the introduction of contaminants by touch contaminationwhen connectors 441 A and 441 B are mated.

The special clamping connector 442 may any suitable device that sealsoff, to prevent contamination. An embodiment of such a connector isshown in FIG. 3, although the sealing and disconnecting functions, to bedescribed below, can be performed by separate mechanisms so thisembodiment is not essential. An outlet tube 460 connectable to thefilter 453 of FIG. 2A is permanently affixed to a male luer fitting 478of a male connector 452 that is received by a female luer fitting 479 ofa female connector 442. The female connector 442 has a pair of latcharms 464 that engage a ridge 469 of the male connector 452. The latcharms 464 pivot on living hinges 468 affixed to the female luer fitting479. Pinching ridges 470 and 476 compress the tube 474 when a bendableretaining ring 472 is squeezed. At the same time, engaging ends 466 ofthe latch arms 464 retract from the ridge 469 releasing the male luerconnector 452. The bendable retaining ring 472 retains its deformedshape once it is pinched so that the tube 474 remains pinched andthereby sealed when the connectors 442 and 452 are disconnected. Thebendable retaining ring 472 may be made of ductile metal, for example.The retaining ring 472 may be replaced by another suitable device suchas a ratchet mechanism.

Returning to FIGS. 2A and 2B, when the multi-use filter device 440 isfirst used, its outlet connector 441A is sealed with a cap 444A as isthe inlet connector 442 (with cap 444B) of the batch container 450. Thebatch container 450 may be sealed and sterilized with the specialfitting 442 and its mating connector 452, which may correspond toelements 442 and 452 in FIG. 3, connected in a completely sealed andpre-sterilized state. Other ports such as a sampling port 454 may alsobe sealed and, if only used as outlets, protected from intrusion offluid by means of a check valve 456 and/or another membrane filter 453(not shown separately). The first time the batch container 450 isconnected to the multi-use filter device, the caps 444A and 444B areremoved and the connectors 441 A and 441 B mated. After filtered wateris collected in the batch container 450, the special clamping connector442 is disconnected and left connected to the multi-use filter device440 to keep it sealed and free from contamination as shown in FIG. 2B.The second time the multi-use filter device 440 is used, the specialclamping connector 442 is removed by means of the connector pair 441 Aand 441 B and discarded while a new batch container's 450 connector 441B is mated to the pre-existing multi-use filter device's 440 outletconnector 441 A. The connector 441 B carries a new special clampingconnector 442 and the same process can be repeated.

FIG. 4 shows an embodiment of a batch container, for example one thatmay be used with the foregoing embodiments, but in particular, with theabove embodiments. The batch container 1 has a batch container, proper,1, a break-off female luer lock connector 4, a y-connector, 5, a pinchclamp 6, a male luer 8, a female luer 26, a sterile filter (e.g., 0.22micron pore or pyrogen filter) 11, a non-reopenable tubing clamp 13, anon-breathing cap 14 on a female luer 9. Line 15 has an in-line checkvalve 16, a pinch clamp 18, a break-off male luer cap 25 and female luer19, and a female luer 21. Various tubing branches 3, 7, 10, 12, 15, 17,and 20 connect these elements. The batch container 1 is delivered to apatient treatment setting as a sealed sterile container with allterminals sealed. The batch container 1 may contain, as delivered, aconcentrate solution sufficient to create a treatment batch of fluid,such as dialysate or replacement fluid, when water is added. Concentratemay be added by means of the luer connector 21. In the tubing setdelivered to the treatment site, the tubing branch 20 may be sealed andcut after the concentrate is added. Water is added at the treatment sitethrough connection to a water source via luer 9. The water is preferablymetered to provide a predefined quantity. The sterile filters should besufficient to protect against contamination by pyrogens before water isadded to the batch container 1. A sample of diluted treatment fluid maybe drawn through the luer 19 before treatment. The check valve 16prevents any contamination due to backflow from the sampling procedure.After water is added to the treatment fluid container 1, the luer 9 isdisconnected from the male luer 8 and the male luer connector connectedto the blood treatment system. Luer connectors are shown by way ofexample as are other features and these are not essential to allembodiments.

FIG. 5 illustrates another arrangement of a particular embodiment whosedescription follows. A pretreatment module 900 provides primaryfiltration from a raw water supply, for example tap water and feedsprefiltered water to a controller module 905 which provides variouscontrol functions, a pump, pressure detection and control, and permanentfiltering capabilities which are not shown separately here. Water ismetered by the control module into a consumable disposable module 910which may provide deionization, adsorption filtration, microporousfiltering, chemical pretreatment, etc. and any other types of filteringthat may require replacement of components. The purified water isfinally conveyed to the batch container circuit 915 discussed withreference to FIG. 4.

Referring to FIG. 6, pretreatment module 900 is shown in more detail. Acheck valve 955 prevents backflow. An air vent 953 removes air from theprimary supply and a sediment filter 951 (which may be replaceable)provides substantial filtering of solids.

Referring to FIG. 7, the control module 905 is shown in greater detail.A shutoff valve 1010 is provided for safety. Pressure indicators 1015and 1025 may be provided for monitoring the respective pressures in andout of a pump 1020. Feedback regulation may be provided to ensure thatconsistent metering is provided if the pump is relied upon for measuringthe total quantity of water supplied to the batch container 1. A highintensity ultraviolet (UV) lamp 1031 provides a both sterilizationmechanism and a mechanism for removing chlorine and chloramines.Preferably, the UV lamp 1030 is of such intensity and wavelength as toprovide disintegration of chloramines. In a preferred embodiment, thelamp is characterized by a 245 nm wavelength and an output power of 750m J/cm² up to 1500 m J/cm² which is sufficient to remove chloramines. Byoxidizing chloramines and subsequently, as described below, filteringusing a deionizing filter, chloramines can be removed.

Note that pressure indicators 1015 and 1025 may be pressure transducersthat feed control signals to a control device such as discussed withreference to FIG. 1 B and to be discussed with reference to FIGS. 13Aand 13B. The operation of pump 1020 may be controlled in dependence onpressure indications from such transducers. For example, if a high headpressure is indicated, an alarm may be indicated and the pump shut down.This may indicate a problem with a connected filter. Also, the pump maybe operated for a short interval and a pressure decay profile recordedand compared with an expected decay profile. If the profile does notmatch, it could be used to indicate a leak (such as in a filter or line)or a clog in the system. If the upstream pressure goes low, it couldmean that the water supply is turned off or some other fault. Each ofthese events may be indicated by means of an annunciator or display(e.g., see 330 and 380 at FIGS. 13A and 13B and attending discussion)and/or by switching off the pump to avoid damage to the system and tonotify the operator to take corrective action.

Referring to FIG. 8A, the replaceable (disposable or remanufacturable)filter module 910 contains a first stage filter 1007 copper-zinc alloywhich is used to subject the water to a reduction/oxidation process toremove ions. This removes ions through a chemical reaction. Anembodiment is KDF 85 media where about one pound is used for a flow rateof 150 ml./min water flow rate. A activated carbon filter 1005 followswhich is a well-known adsorption type filter. Next three stages ofstrong acid cation (SAC) 1011 and strong base anion (SBA) 1009 filtersfollow in series. The SAC/SBA filter cartridges 1011/1009 are not mixedbeds as typically used in water filtration applications. They separatethe cation and anion stages as illustrated because it has beendetermined to be much more effective at removing colloidal aluminum fromthe treated water. Note that the order of the SCA and SBA beds is notlimited to what is shown and that they can be housed in a singlecanister or multiple canisters. Also note that other components can besequenced differently as well as should be clear from this disclosure.For example, it should be clear that the pump 1020 can be used in apushing arrangement to draw water through the UV lamp and theparticulars of the arrangement are not limiting to the inventionsdisclosed. Also note that the resistivity probe 1022 can be includedwithin a single deionizing filter between previous and followingdeionization stages and employed to similar effect. In such anembodiment, a deionizing filter would have leads or contacts to connectthe probe to an external measurement device or controller.

Note that instead of using layered beds in a single cartridge asdescribed, separate cartridges each containing one of a SBA and SACfilter bed may be used. Also, each cartridge could contain more than onelayer of each to provide similar results.

The resistivity probe 1022 detects ion concentration by contact testingof the resistivity of the water. A signal is generated to indicate thatthis will be the last allowed batch before the system will require thereplacement of the replaceable module 910. Control may be provided as inthe embodiment of FIG. 1B, discussed above. The second filter in thepresent embodiment, which backs up the first stage suffering frombreakthrough, is a mixed bed deionization filter 1031. This ensures thatthe current batch can be completed. A second, final safeguardresistivity or conductivity test is provided with an audible alarm at1025 as a back up safety measure. If the value it detects is above acertain level, the pump 1020 may be shut off and an alarm sounded. Thismay come into play if the resistivity probe 1022 fails, or if thesafeguards discussed with reference to FIG. 1 B are breached. TP is ahydrophobic membrane air vent which allows air in ultrafilters 1035A and1035B to be purged. The ultrafilters 1035A and 1035B may be amicrotubular filter such as used for dialysis. An air vent may also beprovided as shown at 1047. The air vent may, for example, have a 1.2micron hydrophilic membrane that blocks air. There is a hydrophobicmembrane port which allows air to vent from the filter. These areavailable as off the shelf components. Any suitable air eliminationdevice may be used and these features are non-limiting of the describedembodiments. Also, the second stage MBDI type filter 1031 can be alayered deionization filter such as 1002C with the same benefits asdescribed in terms of providing protection against breakthrough. Also,the final resistivity sensor 1025 can be located as shown or moved toanother location downstream of the final deionization stage, such asafter or between the ultrafilters 1035A and 1035B, and the configurationshown is not limiting of the invention.

Note, it should be clear that resistivity probe 1022 may be used in aconfiguration such as that of FIG. 1 B, with the resistivity probe 1022corresponding to sensor 405 such that filter module 910 corresponds tofilter module 425.

A simple device for enforcing against re-use or use of an expired deviceis to employ a fuse that the system burns out when a component is firstused. For example, the disposable filter module 910 described withreference to FIG. 8A may be fitted with a fuse 1026 that is burned outwhen first connected to the controller module. The condition of the fusecan be detected if the same module is later connected to the controllerand the controller may the prevent its re-use. In a broad sense, such afuse embodiment may be considered a type of data carrier whose state ischanged to indicate a first use. The same device may be used when themodule is determined to have been expired, for example if a contaminantbreak-through is detected by resistivity sensor 1022. Thereafter, thedisposable filter module 910 may be prevented by the controller frombeing used after an attempt to reconnect by burning out a fuse orupdating a data carrier to indicate the break-through (“expired”)status.

Note that two separately-housed ultrafilters 1035A and 1035B areserially interconnected. The separate housings ensure against failuremechanisms such as grow-through of pathogens, adjacent simultaneous orshared seal failure. For example, prior art reference US PatentPublication No. 2003/0105435, cited in the Background section, shows afilter cartridge with two microporous membranes in adjacent layers of afilter cartridge housing. These may share a seal mechanism or adjacentseals such that failure of the seal of one necessarily involves failureof the seal of the other. Also once a grow through problem occurs inone, the adjacency may cause the problem to creep directly into theadjacent membrane. These problems are prevented by the illustratedarrangement of separate redundant ultrafilters.

Note that the benefit of separately housed filters may be substantiallyprovided in a single housing by substantially separating two ultrafilterlayers. Referring to FIG. 8B, for example, a multilayer filter withvarious types of filter elements housed in a common cartridge 1052contains two ultrafilter layers 1050A and 1050B. The two ultrafilterlayers 1050A and 1050B, separate membranes, are kept apart my anintermediate layer 1056, which may be a spacer or another filter medium.Separate seals 1057A and 1057B, which are also spaced apart, areprovided.

Note the final conductivity/resistivity sensor/alarm 1025 may controlthe pump, as noted. A controller 1090 may be connectable to thedisposable filter module 910 and configured to stop the pump 1020. Thetrigger resistivity safety level to cut-off the pump 1020 may be 1megohm, but may be raised to 2 megohm to allow the use of requiredtemperature compensated resistivity probes (an FDA & AAMI requirement)This does allow use of low cost in-line resistivity probes in thedisposable filter module 910.

Preferably, the filter module 910 as well as the modules of otherembodiments are of such a flow rate that upward flow of fluids ispossible. Generally, prior art deionization beds suffer from the problemof floating or loosening resin particles which may have been disturbedduring handling. The separation and floating of the particles breaks upthe beds and renders the filters less effective. To avoid this,generally, filter systems are configured to direct flow downwardlythrough the beds to help keep and compress the resin particles. But ifflow rates are kept low, as may be done in the present system, water maybe flowed in an upward direction which helps to eliminate air fromstream. Air is a notorious problem in the preparation of medicamentssuch as dialysate. The precise flow rates needed to allow upward flowwill vary according to the characteristics of the system. One way toallow faster flow rates without being hampered by break away resinparticles is to provide a bed compressor of resilient porous material tocompress the bed. Referring momentarily to FIG. 12, 5 in a filtercartridge 1 150, a resilient compression layer 1140 urges the filtrationmaterial 1145 in a downward direction. The resilient compression layermay be any suitable polymeric or rubberlike material that is compatiblewith the application.

The following is an example procedure for using the devices discussedwith reference to FIG. 4.

1. Remove the dialysate concentrate tubing set 915 and remove the cap 14from the tubing line 7 that contains the filter 11. (The 0.22 micronfilter 11 provides additional protection from inadvertentcontamination.)

2. Connect the outlet line 404 to the concentrate bag luer 5 connection9.

3. Break the frangible luer connector 4 which connector is configured toform a permanent seal on the side facing the Y-j unction 5 whendisconnected.

4. Add predetermined quantity of water into the concentrate bag usingthe purification plant through tubing branch 7 through luer connector 9.

5. Optionally a user can write on the bag label the date and time waterwas first added to the concentrate bag, to assist in ensuring that it isused within a period of time. An automated scheme may be employed aswell.

6. Shake the batch container 1 well to mix.

7. Confirm solution conductivity prior to use. Remove the break-off cap1 and draw sample from this branch 15. After removing the sample, clampthe line using the pinch clamp 17 provided.

8. (The following is normative according to a preferred embodiment andnot limiting of the invention) Conductivity must be in the range 13.0 to14.4 mS/cm. Nominal conductivity for the dialysate solution is 13.7mS/cm at 25° C. If conductivity does not meet this specification do notuse it. Verify that the results are accurate. If conductivity is highadditional water may be added to bring it within specification. Ifconductivity is low then the solution must be discarded.

9. Using the non re-opening clamp 13 provided, clamp the line that isconnected to the water purification plant.

10. The clamp 6 is, next, clamped on the line that is connected to thedialysate bag 1.

11. Disconnect the water source at the luer connection 26.

12. Connect the bag of dialysate solution to the dialysis circuit at theconnection 8. This leaves the filter 11 and permanent clamp 13 in placeto protect the water supply source.

13. Unclamp the line going to the dialysate bag using clamp 6, andinitiate treatment after verifying that dialysate will be used within 24hours from when water was added.

Referring to FIGS. 9A and 10A, a batch container 100 has a fluid qualitysensor 135 of a probe 120, such as a contact-type conductivity sensor.The latter may simply be two metallic surfaces separated by a knowndistance and of a given area that has been calibrated. A cage 136 in asupport 105 sealed to the wall 130 of the batch container 100 which maybe a polymer bag as typically used in the medical industry. The cage 136prevents an opposing wall (not shown separately) from preventing fluidfrom circulating around and through the cage and in contact with theprobe such that a reading of the probe 120 is improved. The probe 120extends from the support 105 and has a lead 122 with a signal connector125 that can be connected to a controller (discussed later). The probe120 is an independent element and can be used with any of theembodiments so its description here in combination with other featuresis not intended to be limiting. Note that preferably, the probe assemblyis permanently sealed to the batch container such that there is nopossibility that contaminants can enter the batch container 100interior.

At 110, a fitting connecting a sample or feed line 145 is shown. Thelatter may be used, with a connector 156, connect a sampling syringe todraw out a sample of a medicament or infusate. A check valve may beprovided at 155 to prevent ingress of contaminants. A clamp (not shownseparately) may be provided as well to guard against contamination. Inan alternative embodiment, line 145 may be configured for injecting asoluble concentrate into the batch container 100 before the container100 is sealed and sterilized as a unit (for example, by gamma raysterilization). When a prescribed quantity of purified water is added tothe batch container, the diluted concentrate may form a medicament orinfusate such as replacement fluid for hemofiltration or a dialysate forhemodialysis. Line 145 may also represent a draw line that may beconnected to a treatment machine. In the latter case, a sterile filter(at 155), such as a microporous membrane of 0.2μ may be provided toguard against touch contamination. Additionally, a clamp may be providedas at 155.

In the embodiment of FIG. 9A, purified water may be added to the batchcontainer by another instance of a line similar to 145. Alternatively,if concentrate or other medical solute or medication is contained in aseparate container, such may be added to the batch container 100 bymeans of a double lumen spike 174. (Details of a suitable dual lumenspike can be found in US Patent Publication No. 2004/0222139, which ishereby incorporated by reference as if set for in its entirety herein).A spikable bag 170 contains, for example, medical fluid concentrate suchas concentrated dialysate. Purified water is pumped through connector182 of line 180 and passed into the bag (after spiking) by the duallumen spike 174. The fluid circulates in the bag carrying its contentsback through the dual lumen spike 174 through line 172, through a filter150 into the batch container. The dual lumen spike may be sealed bymeans of a removable cap 175 so that the batch container and fluid linescan be sealed and sterilized and later delivered as a unit withoutcontamination. Clamps 157 may be provided to seal the batch container100. A special clamping connector 442 may be provided and used asdiscussed with reference to FIG. 1 B in line 180. If concentrate ispresent in the batch container 100 rather than using a spiking bag 170,the concentrate may be used to obtain a data point for a calibrationline fit for measuring fluid conductivity.

Referring to FIG. 9B, instead of providing a conductivity or resistivitysensor in the batch container 100, a dual lumen takeoff 255 with acommon lumen (Y-configuration) 260 housing a water quality sensor 262 ofa probe 210 with corresponding signal connector 220 and lead 215. Asyringe port 240 and check valve 242 are connected inline to the otherbranch of the Y-junction. When a syringe (not shown) is attached andfluid drawn into it, fluid from the batch container passes over thewater quality sensor to allow its quality to be measured. In otherrespects the elements of FIG. 9B are the same (and identically numbered)as those in FIG. 9A.

Referring to FIG. 11, a replaceable multiple use filter module 1125 asmay be used in the various embodiments described herein has an inletport 1130 and an outlet port 1110. A physical arrangement of filtercartridges 1111 is shown which provides for a compact module 1125 thatis advantageous for packaging and assembling to a chassis (as discussedrelative to FIGS. 13A and 13B). Tubing 1116 runs from the top of eachcartridge 1111 to the bottom to provide upward flow as discussedearlier. A signal port 1100 for reading fluid quality sensors 1115 and1105 is provided in a housing 1127. Signal port 1100 may have a leadwire and connector installed to it or one may be provided separately.Alternatively, signal port 1100 may be a wireless port powered by abattery. Signal port 1100 may include a data carrier as discussed withreference to FIG. 1B or a data carrier may be provided separately orwithout the signal port if a fluid quality sensor is not provided.

A data carrier may include software and instructions for using thefilter module 1125. These may be read by a permanent component of afiltering system as described in connection with FIGS. 13A and 13B. Abase unit 335 may be configured substantially as described withreference to FIG. 5 with the base unit 335 housing the components of thepermanent pretreatment module 900 and controller module 905. The baseunit may contain a display 330, such as an LCD display. Instead of, orin addition to, a display, the base unit (and other embodimentsdescribed herein) may have a voice generator or other type of outputdevice. An inlet port 341 may be provided for receiving raw water to befiltered and an outlet port 340 for attachment to a filter module (whichmay be multi- or single-use) which is received in a locating station315. The latter may have a reader 311 to read a data carrier or toconnect with a fluid quality probe such as one or more conductivitysensors described above. A further locating station may be provided suchas 305 for a batch container. This may have a data carrier reader 320and/or various other components (at 321) such as a heater, a mixer, suchas a moving field generator for magnetohydrodynamic mixing of thecontents of an installed batch container. The base unit 335 may have aport 310 for connection to a fluid quality probe of the batch container.This may provide a calibration input as well as a final measurement offluid quality. The embodiment of FIG. 13B additionally provides alocating station for a concentrate container such as 170 described withreference to FIGS. 9A and 9B. The base unit 335 may further be fittedwith a controller containing a computer with a connection to theInternet or other network connecting the base unit with a server 390.

In an embodiment, features indicated at 301-306 may be added to allowthe base unit 335 to control when and whether an outlet line of a batchcontainer should be opened and clamped. A batch container is fitted inthe station 305 and an outlet line of the batch container fitted betweenclamping portions 303 and 304. A detector 306 verifies that the line hasbeen fitted in place. When the system is run, an actuator 302 and motor301 may be activated to clamp the line during fluid purification and asthe batch container is filled. After the batch is filled, the clamp mayremain closed until a treatment operation, which may be run while thebatch container remains in place, is begun. At treatment time, the clampmechanism 303 and 304 can enforce the expiration time of the batch offluid. For example, a timer can be started within the controller of thebase unit or, equivalently, a time/date stamp stored and the clamp onlyreleased if the batch of fluid is used for treatment within a certainperiod of time. For this purpose a treatment machine and the base unit335 may be combined into a single device under common control or the twomay be linked by a data link to operate cooperatively to achieve such aresult. The flow chart of FIG. 15 describes the control steps involved.

Referring now to FIGS. 9A and 10B, instead of a concentrate container inthe form a spikable bag 170 as illustrated in connection with FIGS. 9Aand 9B, a cartridge 271 as illustrated in FIG. 10B may be used. Here,concentrate 280 is within a sealed cylinder 274 with a piston 273 and aburstable seal membrane 275. The cartridge may be fitted in the baseunit 335 (FIGS. 13A and 13B) which may contain a linear drive 270 andplunger 272 to push the piston 273 thereby bursting the seal membrane275 and inject contents into a T-junction 278 in the path of purifiedwater sent into the batch container 100. Note that the cartridge 271 maybe provided as part of the sterile batch container fluid circuit shownin FIG. 9B.

Referring to FIGS. 14 and 15, the base unit 335 and corresponding partsof other embodiments described herein, may contain a programmablecontroller including an embedded computer 600 with memory, non-volatilestorage, communication elements, etc. Various sensors 605 such asdiscussed in connection with various embodiments may be connected toprovide input to the controller executing a program stored in memory.The latter may stored in firmware or obtained from a data carrier via adata port 610 as described previously. In addition, a network orInternet connection to a server 625 may be provided to obtain andtransmit data such as software, instructions for use, expiredidentification codes, etc. Actuators 615 such as valve clamps, pumps,and annunciators 620 such as alarms may be provided as well.

A sample program for operating the various embodiments described hereinis shown in FIG. 15. The process may begin with firmware until softwareloaded at a later stage takes over. Software may be read from a dataport or data store and instructions for using the system output at stepS5 whereupon the system waits for user input. The instructions mayindicate to press hard or soft key to continue at which point steps S10and S15 are executed to determine if a no-go condition exists. If anecessary component (S 10) has not been connected, step S30 will beexecuted and the system may output an appropriate message to instructthe user to take corrective action and wait for response. Similarly, ifin step S15, it is determined that a component is expired, such as abatch bag that has been previously used or a filter module has been usedand previously indicated as having suffered breakthrough, step S30 willbe executed. At step S20, various system tests may be performed such asa pressure profile test or quality test. Tests may also includedetermining if the conductivity indicated by a connected conductivityprobe is within specified limits. In step S25 it is determined if alltests have been passed and control passes to step S35 where fluidpreparation is begun. If not, step S30 is performed and appropriateoutput is generated on a display such as 330. If a value goes out ofrange at step S40, control passes to step S60 to determine if anexpiration event has occurred, for example, breakthrough of contaminantsin a filter module. Note that Filter modules may be “stamped” with apermitted time of use after a first use when presumably the seal wasfirst broken. This may be enforced in the same manner as discussed withreference to attempted reuse of a filter module after breakthrough wasdetected. Thus, step such an event may be detected at step S60 as well.

At step S55 depending on the type of data carrier (e.g., programmable orjust carrying a unique ID), the expired or spent unit is indicated asexpired so that reuse can be prevented. For example, in S55 the datacarrier may be programmed with a token to indicate that the attachedfilter module is expired or a server may be sent a message to indicatethat its unique ID should be added to a list of expired IDs. Anysuitable device may be used to “expire” a unit. Since expiring a unitmay still allow a batch to be prepared, control returns to S40.Completion of the treatment may be determined at step S45 by measuringthe total mass pumped or by other means. For example, if the embodimentprovides a conductivity probe in the batch container, step S45 maydepend on the measured conductivity of the batch contents. Oncecompletion is determined, the system may be halted at step S50 and thebatch bag “stamped” with a time and date. Note that further instructionsmay be output at this point.

In one embodiment, the water purification and treatment may be done froma single apparatus and under common control. The steps following stepS50 illustrate this. Assuming purified fluid has been added to a batchcontainer of some description such as those described in the currentspecification or some other, the contents of the container may be mixed,if a solute is involved, and the contents checked in some way in stepS51. For example, the conductivity of a mixed batch or the resistivityof a pure batch can be checked determine its conformity with treatmentspecifications. In step S52, if a value is out of range, control passesto step S30, but if not, the batch may be utilized at any time up to anexpiration time/date (MTU time, or Mixed Till Use-time). In step S53, anoutlet clamp that prevents fluid from being drawn from the batchcontainer is released to allow a treatment to be performed with thefluid product. At the same time, an acceptance message can be output tothe user on a display. At this time, in S54, a time stamp is stored or atimer started to keep track of the expiration of the batch of fluid. Ifthe expiration is not observed, which is tested at step S56 by checkingto see if the timer has expired, the clamp will close in step S30 (underthe general step indicated as “take action”) and an appropriate messageoutput. The system will then wait until treatment is completed while,optionally, continuously checking the MTU timer in steps S46 and S56.

Note that many of the described mechanical and control features arenovel and inventive alone, as subcombinations with other features andtheir description in combination in the above embodiments is notintended to be interpreted as limiting of the inventions disclosedherein. Referring to FIG. 16, when a treatment machine 700 attempts touse a batch container 710 tagged with an expiration date at step S50, itcan determine if the date has passed and prevent use of an expired batchcontainer thereafter. This may be implemented with contact or wirelessdata reading devices, a programmed smart card type device or via anInternet server as described with reference to the mechanism forenforcing non-reuse of filter modules.

Referring to FIG. 17, air may evolve from fluid as it passes through anultrafilter 714. Preferably, the ultrafilter 714 has a high membranesurface and in such filters, the potential for air evolution may befairly high. To avoid problems with bubbles forming in the filter, theembodiment of FIG. 8A shows transducer protectors TP, which arehydrophobic air vents. But the lines leading to them can fill with waterand render them useless for air purging. A refinement of theconfiguration of FIG. 8A, which may be used in any water treatment plantas a final protective stage, is to provide an ultrafilter 714 (which maybe a standard dialyzer capped at the lower blood port) with an inlet 712and outlet 704 on one side of the membrane connected by a return line704 flowing through an air filter/vent 706, through further line 708into a T-junction 717 and back into the inlet line 712. Ultrafilteredfluid is drawn out through line 707. Again, the filter/vent 706 may be a1.2 micron air vent with a 1.2 micron hydrophilic membrane that blocksair and a hydrophobic membrane port which allows air to vent from thefilter. These are available as off the shelf components. The watercolumn defined by line 708 is denser than the corresponding columnwithin the housing of ultrafilter 714 so that a return flow will existthrough the branch 704, 706, 708. The reason for the lower density isdue to the evolution of air in the ultrafilter 714.

An alternative design that integrates air vent configurations into thehousing of the ultrafilter 714 is shown in FIG. 17A. For the outlet(filtrate) side of the media, an air vent, e.g., a hydrophobic membranetype air vent 765 may be integrated into the outlet of an ultrafilter715 and an air filter such as a hydrophilic air filter membrane 766integrated into the outlet. Any bubbles coming out of fluid collect atthe top of the filtrate side (in a header space of a microtubularmembrane type filter) and be vented by the hydrophobic air vent 765. Onthe inlet side of the ultrafilter 715 (the side of the filter media thathas not yet been ultrafiltered), air collecting in the inlet side willleave by an air vent 467, for example one using a hydrophobic membrane469. A check valve 742 may be provided to prevent siphoning and/orreduce risk of contamination.

Referring to FIG. 18, to address any problem with inadequate flowthrough the return branch of the FIG. 17 embodiment, a resilient channelelement 730 such as an inline bladder 731 may be included with checkvalves 724 and 728. When the system pumps fluid, the resilient channelelement 730 stores fluid under pressure and releases it in pumpingfashion when the system stops pumping. Again, an air filter/vent 724allows air to escape and purged from the return line 726. The returnflow problem can also be dealt with by replacing the T-junction 717 witha Venturi device configured to create a suction in line 708 by using anaccelerated fluid flow through the line 714,712.

One of the drivers for the features discussed above is a need to providepure water irrespective of input water quality. The above embodimentsare not reliant upon water quality and are designed to reliably producepure water or solutions regardless of input water quality. Variousembodiments are also designed to reduce the costs associated with lowervolume (10-60 liters) preparation of medical and other pure solutionsand to maintain simplicity through the combination of semi-permanent andsingle-use modules which combine to eliminate the complexities, costsand safety issues associated with maintenance, sterilization, andoperation of many other prior art systems.

In the following sections, systems are described which is configured toprepare batches of medical fluid, such as dialysate for dialysis orreplacement fluid for hemofiltration. The systems according to exemplaryembodiments produce and store a single batch that contains enough fluidfor multiple treatments. In a preferred embodiment, the fluid isprepared such that it has a very low rate of endotoxins and containssolutes that are compatible with storage for multiple days, such aslactate-based dialysate. The embodiment purifies water, dilutes alactate based dialysate concentrate to form a batch, for example of 80I. volume. The batch is stored for a specified period of time and usedfor frequent low-volume treatments, for example, three daily treatments.The system provides safety systems that enforce adherence to storageterm constraints, purity, fluid and quality. In addition, the systemstrikes a unique balance between the risks long-term storage ofmedicaments while keeping available for immediate use, treatmentfrequency, volume of fluid, portability of the storage unit, and otherfactors to provide an overall positive impact on patient lifestyle andwell-being. The features, in combination, include:

1. Frequent treatment with moderate clearance (e.g., daily) may beselected as a treatment regimen according to one preferred embodimentalthough this is not required;

2. Preparation of treatment fluid every several days (e.g., every threedays);

3. Storage at a temperature that allows immediate fluid withdraw fortreatment purposes between fluid preparation steps;

4. 1 and 2 can be accomplished with fluid volumes of 80 I. or so, forexample. Such a quantity, which may also correspond to other treatmenttypes, is a convenient quantity for a portable unit such as one that canused at a residence.

5. A consequence of 2 is that the task of preparing fluid can be done attimes other than treatment times (i.e., out of synch with treatments)thereby permitting a patient's schedule to be more flexible and alsoreducing the length of time spent performing the treatments because thepreparation does not have to be done as part of any of the treatments.

6. Enabling the generating purified fluid at a patient's residence orother convenient treatment site avoids storage requirements.

7. Employing water purification based on deionization (Dl) and storageat usable temperatures, combined with the high treatment-frequency andmoderate clearance can reduce the demands on utility infrastructure,namely water and electrical, because the high power rates for fluidheating and high water rates associated with reverse osmosis areavoided. In other kinds of systems, high power rates are often requiredfor sanitization of the water treatment system. Dl and ultrafiltrationprovides a prolonged use disposable that does not require sanitization.Water usage is reduced through the use of deionization vs. RO, sincethis Dl does not have a “waste stream”.

8. The batch size permits a unitary design and, with compact packaging,may be made no higher than a household side table or no higher thanabout a meter and preferably no higher than about 75 cm, or the heightof a typical table. In a preferred embodiment, the height is about thatof a lamp or end table or about 65 cm.

9. An attractive enclosure that hides components permits anunintimidating and attractive appearance to be maintained if thetreatment site is a residence.

10. The small size permits the enclosure to be made mobile and so theenclosure may be fitted with wheels.

11. A tabletop may be provided on the enclosure to allow different typesof treatment equipment to be supported by it. Preferably, in keepingwith the appearance objectives, the tabletop is not interrupted byprotrusions such as poles, displays, and other fixtures.

12. 11, along with appropriate mechanical design features the allow theunit to output the stored fluid at a pressure similar to the normalmedical fluid bags used for typical medical treatments, may permitconvenient switching from a peritoneal dialysis (PD) cycler unit, untila patient's peritoneum cannot handle PD to extracorporeal bloodprocessing simply be replacing the PD cycler with an extracorporealdevice.

13. The size range for the batch container and an appropriate supportmechanism and leak detection may enable the use of a disposablecontainer to simplify preparation of the batch.

14. Filtration using deionization beds, particularly with a large safetymargin, can be expensive so a long term multi-use disposable componentmay provide a cost balance point while also making it convenient forusers because of the need to replace, for example, only once every monthor even less frequently. In a preferred embodiment, the module isreplaced once every 1-3 months.

15. Multi-day, multi-treatment storage, is enabled by using a lactatebased treatment fluid and a pre-sterilized, disposable container with apreconnected sterile filter that treats all fluid entering the sterile,disposable storage container.

Referring to FIG. 19A, a preferred configuration of such a fluidpreparation and storage 1302 system is shown. A pretreatment module 195receives water from a source, such as a sink faucet 1379, and a UV/pumpmodule 1300 may provide a semi-permanent pre-filtration process asdescribed with reference to FIGS. 6 and 7. The water quantityrequirements are preferably such that ordinary household supplies areadequate—as will be observed, the preferred embodiments described permitthis. The connection to a sink faucet may be by way of a commonconnector that replaces the aerators of many household faucets. A longterm filter (LTF) module, for example, 1305 provides water purificationfor multiple multi-treatment batches, for example sufficient for dailytreatments for 30 days. In a preferred embodiment, the LTF module 1305includes KDF, segregated SAC/SCA bed deionization (Dl), and mixed bedand ultrafiltration as described with reference to FIGS. 2A and 8A. TheLTF module, as also described above, may be in the form of a completelydisposable module which only requires a small number of connections toreplace. Various connectors are shown at 1344.

A disposable circuit 1303 includes a batch bag 1317, and various fluidcircuit elements. Beginning with the connector 1344 for connecting tothe LTF module 1305, a dongle 1361 has of a tubing segment 1360 withrespective connectors 1344 and a non-reopening clamp which ispre-installed and continuous with a feed line 1370. The dongle 1360 maybe as described with reference to FIGS. 2A and/or 3, for example. Thedisposable circuit also includes a path selector, pumping, and shortterm filter portion 1315. An embodiment of the latter is described withreference to FIG. 23, infra. The latter contains a short term filter(not shown here) that is used once for each batch of treatment fluidprepared. A line 1366 may be provided for connection to containers ofmedicament concentrate 1310. Another line 1368 may connect apre-connected and sealed batch container 1317 for storing sufficientmedicament for multiple treatments to a line 1369 via a connector 1344E.Note that the connector 1344E may or may not be provided between thebatch container 1317 and the path selector, pumping, and ST filtercircuit 1315 since they may be supplied as a single presterilizeddisposable.

A source line 1364 may be provided to provide water to a treatmentdevice 1312 such as a hemofiltration machine or peritoneal dialysiscycler. The treatment machine 1312 may include a fluid circuit (notshown separately) which includes a connector 1344A for a source line1372 and a drain line 1362 with a connector 1344B. The may be connectorto mating connectors on a panel (not shown here) of the fluidpreparation and storage system 1303. Connectors 1334B and 1344C of thefluid preparation and storage system 1303 may connect at a Y-junction1397 to provide a single common drain connection 1396 which may beconnected to a sewage service 1393 or to a spent-fluid container 1392.In yet another embodiment, the fluid preparation and storage system 1303may provide a disposable waste container 1313, waste line 1385, and apump 1383 to collect and discharge waste fluid after each treatment orwhen a new batch is prepared (the procedure for which will be describedshortly). The collection of waste in a container is not required in thefluid preparation and storage system 1303 but in some cases it may bepreferred, such as when long term connection to a drain 1393 is notconvenient or when a patient wishes to move the treatment 5 locationfrequently. A fluid quality sensor 1322 such as a conductivity sensor,opacity sensor, bubble detector; is provided in a discharge line 1345 toallow the treatment fluid to be tested for quality by sending a samplethrough the discharge line 1345. The fluid quality sensor 1322 may berinsed in a further step by pumping purified water through the dischargeline 1345.

A pump and one or more actuators in operative association with the pathselector, pumping, and short term filter portion 1315 may be provided invarious configurations to move fluid between selected lines among lines1366, 1369, 1370, 1345, and 1364. An example of a pump and actuators isdiscussed below with reference to FIG. 23. Referring to FIGS. 19B to19H, by moving fluid 5 between selected lines among lines 1366, 1369,1370, 1345, and 1364 the between selected lines among lines 1366, 1369,1370, 1345, and 1364 may perform various operations as follows.

1. As illustrated in FIG. 19B, the path selector, pumping, and ST filtercircuit 1315 may provide for prefilling the batch container 1317 withpurified water by pumping filtered water from feed line 1370 to line1369 of the path selector, pumping, and ST filter circuit 1315. Thepumping may be performed by the metering pump of the pretreatmentpumping module 1285 and/or by means of a pump in the path selector,pumping, and ST filter circuit 1315 portion. The transfer of apredetermined quantity may be established by weighing the batchcontainer, by summing the quantity transferred by the metering pump 1029(FIG. 7), by an optical or mechanical level detector in operativeassociation with the batch 5 container 1317, etc. The quantity in thebatch container 1317 may ensure that concentrate is well-mixed in thecompleted batch and may avoid the need for mixing of the dilutedtreatment fluid within the batch.

2. As illustrated in FIG. 19C, the path selector, pumping, and ST filtercircuit 1315 may provide for the transfer of fluid between lines 1366and 1369 to transfer concentrate from the concentrate container 1310 tothe batch container 1317. The concentrate may be pumped or siphoned.

3. As illustrated in FIGS. 19D and 19E, the path selector, pumping, andST filter circuit 1315 may provide for repeated cycles of diluting theconcentrate in the concentrate container 1310 and transferring rinsed 5concentrate to the batch container 1317. This may be done bytransferring fresh purified water to rinse the concentrate container1310 by flowing water from line 1370 to line 1366 (FIG. 19D) followed bytransferring diluted concentrate from line 1366 to line 1369. Thesesteps may be performed repeatedly until a specified number of cycles ofdilution 0 and transfer are completed. The number of cycles may bedetermined experimentally as sufficient to ensure a repeatable quantityof concentrate is transferred or a certain maximum quantity ofconcentrate remains in the concentrate container 1310. Preferably, theconcentrate is provided in a rigid container that may be effectivelyrinsed by the above process. Other types of container may be used,however, such as hangable medical fluid bags, solute cartridges, etc.Also, preferably the concentrate is one that permits long term storageas a prepared treatment fluid for dialysis. Note also that instead of asingle component concentrate, a multi-component acid component can bemixed with a dry bicarbonate component and used with the present system,particularly if used for acute care and the storage term is limitedsuitably or other means, such as mixing of the batch, are employed toavoid precipitation which may attend the use of mixed bicarbonate-basedtreatment fluid. Other alternatives are possible and are not excludedfrom the scope of invention.

4. As illustrated in FIG. 19F, the path selector, pumping, and ST filtercircuit 1315 may provide for the transfer of fluid between lines 1370and 1369 to transfer purified water to the batch container 1317 andcomplete the dilution of the batch.

5. As illustrated in FIG. 19G, the path selector, pumping, and ST filtercircuit 1315 may provide for the transfer of fluid between lines 1369and 1345 to transfer fluid from the batch contain 1317 to the qualitysensor 1322 to test the quality, for example, the conductivity of thecompleted batch.

6. As illustrated in FIG. 19G, the path selector, pumping, and ST filtercircuit 1315 may provide for the transfer of fluid between lines 1369and 1364 to make the fluid in the batch container 1317 available to atreatment device such as treatment machine 1312.

7. As illustrated in FIG. 19J, the path selector, pumping, and ST filtercircuit 1315 may provide for the transfer of fluid between lines 1369and 1345 to transfer fluid from the batch contain 1317 to the drain 1397junction to empty the batch container 1317. This may be done if thebatch expires 5 before being used or the entire contents of the batchare not required or for other reasons.

In an alternative embodiment, the steps of 19B, 19C, 19D, 19E, and 19Fmay be omitted by providing concentrate in the batch container 1317.Another means of transferring the required solute, such as dry solute,may also be provided according to various mechanisms in the prior artwhich do not require rinsing, such as an inline medicament cartridge(See, for example, Jonsson, et al.: U.S. Pat. No. 4,784,495).

As mentioned, the system 1399 of FIG. 19A may provide batch preparationand storage as well as monitoring functions and support for 5 treatmentsystems. In an embodiment, in overview, the functions that may beprovided are shown in the state diagram of FIG. 20A. From a standbystate, the system may initialize the LTF module 1305 (S172) by primingit and testing its performance. The latter step may involve thereplacement of the LTF module 1305 and in a preferred embodiment wouldbe done on a schedule ranging from monthly to four times per yeardepending on the precise capacity of the LTF module 1305. The system mayperform the functions of creating a batch S174 and holding a batch whilemaintaining its temperature S176. The system may make the batchavailable for use by providing the fluid at a predefined pressure S178.Further functions of draining the batch container 1317 in step S180 andunloading the batch container 1317 by disconnecting in step S182 arealso provided.

FIG. 20B shows a typical flow attending normal usage of various theembodiments of a batch preparation and storage system according tovarious exemplary embodiments described herein. Initially, assuming thesystem 1399 has been fitted with the components of the permanentportions such as a pretreatment module 1295 and UV/pump module and allcontrols are in working order, the typical routine provide a new LTFmodule 1305 at step S135. Then a new batch container 1317 and STFcircuit 1315 may be installed and filled at step S130. The batch may beheld until required at step S99. Heating may be performed during bothsteps S130 and S99. Periodically, or when a user attempts to use abatch, at step S100, the system (e.g., 1399) may determine if the batchis near a point of becoming unusable. This may be established by testingor by determining if it the current time since the batch was created isnear a protocol limit (e.g., >T1−N hours) and if so a warning may begenerated S120. The amount of time that establishes whether a warningmay be generated may be determined based on the duration of a treatment,plus a safety margin. In an exemplary embodiment, the warning intervalis 8 hours so that if a batch normally is considered to be expired 72hours after creation, the warning would be given 64 hours aftercreation. The warning allows the user of the system to use an existingbatch rather than allowing it to expire and then being required to makea new one before being treated.

The warning generated at step S120 may correspond to a conventionalannunciator such as a bell or it may be an automated web server thatgenerates an email, IM message, cellular SMS, cellular voice message,pager alert, or any other suitable message rendering service. The leadtime before which the alert will be generated may made a user-selectableperiod.

In step S105, it is determined if the batch retention period hasexpired, requiring a new batch to be generated. If the batch hasexpired, or if there is insufficient time before expiration to makenormal use of a batch, a warning message to that effect may be generatedas indicated by the dotted lines. The message may or may not beprovided. If the batch has expired, or if there is insufficient timebefore expiration to make normal use of a batch, control step S125 isperformed. If not, a treatment may be performed S110. If the batch isdepleted S140 or a treatment count on a stored batch is reached S115(these may be alternatives in a given embodiment or both tests may bedone), control proceeds to step S125.

At step S125, the system may determine if the LTF module has expired asindicated by a test or by an elapsed time period or both. If the LTF hasexpired, control returns to step S135 and if not, it is determined ifthe batch container needs to be drained. If so, the batch container isdrained and removed and, in either case, control then proceeds to stepS130.

At any point in the control flow, various system tests may be performed.One of the more important is the testing of the quality of waterpurification performed by the LTF module. In step S142, which may beperformed, essentially, at all times, if the LTF module is determined tobe near expiration, as discussed with regard to the resistivity probe1022 in FIG. 8A. In such a case a status (stored as a semaphore in amemory of a controller, for example) of the LTF module may be updated toprevent its use after a current batch is completed. This status may beinterrogated in step S125 and used to determine if the LTF module isexpired. Step S142 represents both the continuous test of the LTF modulecondition as well as the step of updating the status if the conditionwarrants. Also at any point, a breakthrough of contaminants in the LTFmodule, for example sensor 1025 (FIG. 8A) may indicate the instantexpiration of the LTF module at step S144. In that case, step 144includes the initiation of safeguard procedures such as shutting down ofpumps and/or the generation of alarms. Again, alarms may be of any sort,including wireless or web-based messages to users, service providers,treatment supervisors, etc.

Step S135 may include the steps shown in FIG. 21 A. The LTF module maybe housed in a cardboard container provided with an openable compartmentwhere all connectors, including electrical and tubing connectors, arecollected and fed out. In step S210, the compartment, for example in ahousing of cardboard, may be ripped open and connectors removed. The LTFmodule may then be put in place, at step S212, in the filtration andstorage device (e.g., 1399) and connections for inlet and outlet linesand electrical connections, which may be provided on a unitaryfiltration and storage device as described later (FIGS. 24 and 27) maybe made at step S214. The filtration and storage device (abbreviated inthe drawings as BPSD for “Batch Preparation and Storage Device”) may bepowered up at which point at step S216, a controller may perform asequence of self-tests including testing the UV lamp (if present),expiration (LTF module is previously used or unauthorized as discussedabove), and other tests. At step S218, a user may press an actuator(“GO” button) of a user interface to start an automatic prime and purgesequence which may involve flushing the LTF module sufficiently toremove any residual agents used in manufacture of components and theclearing of any air as well as priming. The latter may be doneautomatically At step S230, after the system as finished with theprime/purge sequence of step S218, a non-reopening clamp on a dongle(similar to 1361, FIG. 19A) pre-attached to the LTF module and left inplace until a new batch bag and short term filter circuit is connectedas described further below. Then user may press the actuator (“GO”button) of the user interface to enter the standby mode S232.

During the above procedures, the system may at any point (indicated bystep S299), for example after fluid connections are completed, performpressure test to determine if there are any leaks. In this case, a pumpmay be run (e.g., 1029, FIG. 7) to create a pressure and then thepressure monitored for an interval to see if the relief rate correspondsto one previously determined to indicate a leak. Similarly pressure maybe measured during the purge step of S218 to ensure no blockages arepresent as indicated by a high back pressure or an overly lowbackpressure which may indicate a faulty seal or filter medium. If anyout of bounds conditions are found, step S299 includes the generation ofa corresponding indication or alarm.

FIG. 21 B shows details of step S130 of FIG. 20B. As discussed furtherbelow, the batch container 1317 may be provided as part of a disposablecomponent with preconnected tubing, short term filter, sensors, seals,clamps, etc. The container itself may take the form of a large bag whichmay be shipped in a folded condition such that if laid properly in acontainer and filled, will unfold and expand in a predictable manner.Also, as discussed below, a support container for a large bag may takethe form of a rectilinear box 1630 on drawer glides 1614 (FIG. 24). Sothe first step in installing the container and tubing set disposable maybe to open such a drawer and to lay the bag at the bottom in a specifiedorientation with the tubing and connector portions fed to an accessiblelocation. The tubes may be temporarily wrapped together around an easyto identify component such as the ST filter 1510 (FIG. 23) so that ifthe user holds that part, the tubes are secured from tangling andpositioned in a predictable manner. See steps S250 and S252.

An alignment and retainment mechanism may be provided to secure thetubing and ST filter, for example one is described below with referenceto FIG. 23. One or more steps within step S254 may provide for thealignment of the circuit with actuators, pumps, sensors, etc. and then,in step S256, these may be engaged such as by clamping or securing oneor more actuator components. Examples of the mechanical aspects arediscussed below. Once the circuit is secured, the user may place thesystem in a mode for connecting the concentrate container. This step mayset any valves in position to prevent premature siphoning before thesystem is prepared for the transfer of concentrate to the batchcontainer. This is done in step S258. The tubing dongle that protectsthe outlet of the LTF module is then removed in step S260 and the outletfrom the LFT module is connected to a connector for the ST filter andbatch container circuit. This connection corresponds to, for example,FIG. 19A reference numeral 1344Q. The circuit 1303 may contain a newdongle with a non-reopenable clamp 1740 which may be used later toprotect the LTF module after the batch container and ST filter circuit1303 unit is removed.

Next, at step S262, the user may invoke a batch preparation procedure,according to the current user interface by pressing GO. The proceduremay begin by checking water quality S264 using the resistivity sensor1322 (FIG. 19A) by pushing a test sample out the waste junction 1397.The system may then, at step S266, perform pressure test to determine ifthere are any leaks. In this case, a pump may be run (e.g., 1029, FIG.7) to create a pressure and then the pressure monitored for an intervalto see if the relief rate corresponds to one previously determined toindicate a leak. Also checked are high back pressure or overly lowbackpressure which may indicate a faulty seal or filter medium. Thecondition of a UV light source, if present may also be checked by meansof a light sensor. This step S266 may be performed at other points aswell.

The flow director (not shown here, but described with reference to FIG.23, is then configured as described with reference to FIGS. 19B through19H and 19J in steps beginning at step S268 to provide the functions ofadding concentrate to the batch container and diluting to the correctdegree. Step S270 corresponds to adding the initial quantity of waterbefore the transfer of concentrate described above with reference toFIG. 19B. Step S272 corresponds to the transfer of concentrate to thebatch container described with reference to FIG. 19C and the rinsingsequences described with reference to FIGS. 19D and 19E as well as thefinal completion of the dilution process described with reference toFIG. 19F. Step S274 corresponds to the fluid quality test, which mayinclude a conductivity test, described with reference to FIG. 19G. Thecompleted batch is warmed and held at a temperature compatible with usebeginning at step S276. As above the various out of bound conditions maybe tested and confirmed at various points during the process of FIG. 21B as indicated by step S299.

Referring now to FIG. 21C, details for step S110 are indicated whichcorrespond to the process of using a batch of treatment fluid. At stepS300, a treatment circuit and/or device is provided. Fresh and spentfluid lines may be connected as required by the particular device instep S305. In the FIG. 27 embodiment described below (for example—trueof other embodiments as well), the fresh fluid and waste fluidconnections are provided so the connections may be made between thebatch preparation and storage device and the treatment device. In stepS310, the user may press GO or otherwise place the batch preparation andstorage device in a treatment mode in which the system may run a pump togenerate a head pressure equivalent to common gravity fed lines that usea hung medicament bag. The batch preparation and storage device may makethe fluid available for treatment in other ways as well, for example bysimply configuring valves, for example by configuring as described withreference to FIG. 19H. The treatment may be performed using the systemas indicated at step S315 and then, if needed, the batch may be drainedor the system placed in standby mode where the batch temperature ismaintained until the next treatment (step S320). As above the variousout of bound conditions may be tested and confirmed at various pointsduring the process of FIG. 21 B as indicated by step S299.

FIG. 24 is a more detailed description of a batch preparation andtreatment system which is consistent with the embodiment of FIG. 19A. Apretreatment module 195 receives water from a source, such as a sinkfaucet 1379, and a UV/pump module 1300 may provide a semi-permanentpre-filtration process as described with reference to FIGS. 6 and 7. Thewater quantity requirements are preferably such that ordinary householdsupplies are adequate—as will be observed, the preferred embodimentsdescribed permit this. The connection to a sink faucet may be by way ofa common connector that replaces the aerators of many household faucets.A long term filter (LTF) module, for example, 1305 provides waterpurification for multiple multi-treatment batches, for examplesufficient for daily treatments for 30 days. In a preferred embodiment,the LTF module 1305 includes KDF, segregated SAC/SCA bed deionization(Dl), and mixed bed and ultrafiltration as described with reference toFIGS. 2A and 8A. The LTF module, as also described above, may be in theform of a completely disposable module which only requires a smallnumber of connections to replace. Various connectors are omitted fromFIG. 22 because their description is not necessary. Like numerals (inFIGS. 19A and 22) specify similar components so their description is notduplicated here.

A particular example of a path selector, pumping and ST filter circuit1315 is indicated at 1499. Four valves 1416, 1418, 1414, and 1412 and apump 1464 are independently controlled by a controller 1497 to providethe selectable paths described with reference to FIGS. 19B through 19Hand 19J. The valves are preferably pinch valves that press on medicaltubing to open and close. Note that fluid may be prevented from beingpumped into the batch container (in the present embodiment a batch bag1444) by a check valve that has a lower limit requirement before itopens (a “cracking pressure”). So, for example, when water is pumpedinto the concentrate container 1404, it is not necessarily pumped intothe batch bag 1444. The dialysate pump 1464 may also prevent water frombeing pumped into the batch bag 1444 as well. The following list showsthe valve configuration and pump configuration for the modes of FIGS.19B through 19H and 19J. The forward and reverse pump directions areindicated at 1467 and symbolized by “F” and “R” in the table below. Thestate of the pump 1464 being off, and thereby acting as a closed valve,is indicated by “X.” The valve configurations are indicated by “C” forclosed and “0” for open.

TABLE 1 Flow director configurations FIG. number 1418 1416 1412 1414Pump 19B O C C C R 19C C O C C R 19D O O C C X 19E C O C C R 19F O C C CR 19G C C C O F 19H C C O C F 19J C C C O F

Fluid warmer 1452 may be thermostatically controlled using a temperaturesensor 1448. A leak sensor may be provided at a location in the support1456 for detecting any leaks from the batch bag 1444. A weight scale1451 may be used as an alternative further means of determining thequantity of fluid transferred to the batch bag 1444. The batch bag maybe supplied with concentrate already in it so that the above stepsrelating to transfer of concentrate from a separate container may beomitted.

The valve assembly may be as shown in FIG. 23, with a pinch actuators1534, 1518, 1522, and 1536, compressing tubing branches 1534, 1516,1524, and 1528, respectively against an anvil plate attached to a door(not shown in FIG. 23) that closes over the assembly. The door is hinged1530 and latches 1532 such that the tubing branches 1536, 1516, 1524,and 1528 are compressed when the pinch actuators 1534, 1518, 1522, and1536 are activated (moving toward the viewer from the perspective thedrawing page). A pump tubing segment 1546 is held against the rollers ofa peristaltic pump actuator 1544 by a pump race segment attached to thedoor. Tubes 1536, 1516, 1524, 1528, 1546, and 1520 in FIG. 23 correspondto lines 1366, 1469, 1345, 1370, 1462, and 1460, respectively, in FIG.22.

Leak sensors 1486 and 1490 may be provided to detect leaks around orwithin the corresponding modules 1300 and 1305. A common waste junctions1434 has connectors 1432 and 1438 for receiving fluid from the batchpreparation and storage device and from the treatment device (not shownhere, but the corresponding connection is 1344B in FIG. 19A). Theconductivity sensor 1428 corresponds to the sensor 1322 in FIG. 19A.check valves 1430 are provided for each branch 1422 and 1431. Extraconnectors may be provided for convenient replacement of components asshown.

A branching connector junction 1402 provides multiple connections forthe fluid inlet of a treatment device (not shown here). To help ensureagainst touch contamination, each connector 1742A, 1742B, and 1742C issealed before use. Each connector is, in turn, unsealed and connected tothe inlet line 1745 of the treatment device (as is connector 1742B inthe figure) while the other connectors remain sealed (as are connectors1742A and 1742C). When a treatment is completed, a non-reopening clamp1740 of the previously used connector (1742B) may be closed and thetreatment device inlet line 1745 may be disconnected. This prevents anyincursion of contaminants back into the fluid circuit or batch bag 1444.Alternatively, a check valves may be used in a single branch, but thepositive seal provided by this multi-branch connector junctions 1402 ispreferred.

To provide a stable and predictable source fluid pressure, similar tothat provided by a fluid bag hung above a treatment device, in asituation where the batch container is below the treatment machine as itis in the preferred embodiment (See FIG. 25), a recycling loop 1462 and1460 is provided. When the pump 1464 pumps in the forward direction, anyresistance forces fluid backward through the check valve 1472, which ischaracterized by the above-identified cracking pressure. An exemplarypressure is 3.5 psi. Thus, during treatment, the pump 1464 runscontinuously feeding fluid back into the container while the line 1469remains substantially at 3.6 psi. If the line 1369 ascends a substantialdistance, the pressure may be lowered and the final pressure “seen” bythe treatment device may be provided at any desired value.

FIG. 23 illustrates an embodiment of the user interface/door 1640 whichmay provide a surface against which the valve actuators 1534,1518, 1522,and 1536 operate and may position a pump race against the rollers ofperistaltic pump 1544. A convenient mechanism for positioning the fourtube portions 1536, 1516, 1524, 1528, 1546, the short term filter 1510provides a rigid casing that supports junctions 1538 and 1542. Thecasing of the short term filter 1510 may be positioned and engaged in aholder, for example as indicated by brackets 1512 and 1514, to align theentire assembly. A support 1513 for the pump tubing portion 1546 mayalso be provided. A more extensive fixture may be used such as vacuummolded tray to hold the pump tubing portion 1546 as well as the our tubeportions 1536, 1516, 1524, 1528, 1546 and the short term filter 1510could also be provided so that loading is simplified.

FIG. 24 illustrates a preferred configuration for the batch filtrationand storage device 1600 consistent with the embodiments described above.A unitary cabinet 1601 is provided with utility connections in back (notshown) for water supply and draining, and AC electrical feed. A drawer1630 holds the batch bag 1444. tubes may be fed out of the drawer 1630and directly behind the user interface door 1640. The tubes that connectto the treatment device, positioned on top of a table 1612 surface, maybe fed through a notch 1641 to the treatment device. An example of atreatment device 1660 sitting on the table surface 1612 is shown in FIG.25. The LTF module 1624, and also shown in FIG. 26, slides into acorresponding space within the cabinet 1601. A compartment 1626 can beopened (this may be done before inserting the LTF module 1624) andconnectors of the LTF module 1624 conveniently mated to connectors 1632on the batch filtration and storage device 1600. The embodiment of FIG.24 has a separate pump portion as indicated at 1602. The UV/pump module1300 may be located in a horizontal configuration as indicated at 1616and slidable out of the cabinet. A door 1610 allows the majority of theunits internals to be concealed during operation and a port 1608provides access to the control panel 1604 built into the user interfacedoor. An additional door 1622 covers the LTF module 1624. Wheels 1618may be provided to permit the unit to move around.

The packing of the components of the LTF module 1680 according to anembodiment thereof, is illustrated in FIG. 26. The carbon/KDF module1007 SAC/SBA cartridges 1002A-1002C and the mixed bed DI module 1031described with reference to FIG. 8A are arranged in flat array asindicated at 1624. The various resistivity sensors 1684 and theultrafilters 1682 and air filters 1688 (corresponding to 1035A and B and1047 in FIG. 8A) are also arranged in the same plane. Connectors andlines fit into the compartment area 1686.

Referring to FIG. 27, a fluid circuit configuration for the treatmentdevice allows for separate blood and dialysate circuits in a dialysisembodiment. Since the treatment fluid batch can be retained and storedfor a period of days, it may be convenient to provide a fluid circuitthat is retained for the same period, necessitating the exchange of onlythe blood portion of the circuit. This may simplify set up, reduce therisk associated with improperly installed components, and reduce costsomewhat. Here, the treatment device is indicated at 1735 and the Batchpreparation and storage device at 1725. The batch bag is indicated at1720. The check valve 1792 that provides the head pressure to feed thetreatment device 1735 from below the treatment device 1735, asillustrated in FIG. 25, and feed line 1788 are also shown. The pathselector circuit portion 1315 is described above and may be according toany of the embodiments or others. Other lines 1786, 1784, and connectors1740, 180, 1782, 1762, and 1778 and the lines connecting them to thepath selector circuit portion 1315 may be pre-connected to a balancingcircuit 1700 that forms part of the treatment device 1735. Respectivemating connectors 1764, 1766, and 1768 on the batch preparation andstorage device 1725 may be provided such as indicated in FIG. 24 at1632. The balancing circuit 1700 may be a volumetric balancing circuitas described in U.S. Pat. No. 6,638,478 which is hereby incorporated byreference as if fully set forth in its entirety herein. A blood filtercircuit portion includes a filter (e.g. a dialyzer) 1715, blood lines1760 and blood pumping and sensor circuit 1705, venous and arteriallines 1758 and 1759 and possibly other components. The venous andarterial lines 1758 and 1759 are shown connected to an infusible fluidbag 1756 for priming of the blood circuit which may be done with aninfusible fluid delivered in the infusible fluid bag 1756. A doubleconnector 1754, 1756 may be provided to allow fluid to be circulatedthrough the infusible fluid bag 1756 allowing gases to settle out.

Note that the batch preparation and storage device may provide fluid forpriming the blood circuit by pushing treatment fluid through the bloodcircuit filter 1715 into the blood circuit 1705 and into the infusiblebag 1756. In this case, the infusible bag may be provided as part of theblood circuit 1705 and preattached as illustrated. Note also that it iscontemplated that a patient access would be connected in someappropriate fashion after priming is completed by disconnecting theconnectors indicated figuratively at 1752 and 1754.

A multiple connector 1746 may be provided which is the same as, and usedin the same manner as that indicated at 1402 and described withreference to FIG. 22. For each treatment, the blood filter portion 1798is replaced after the treatment is completed. The non-reopenableconnector 1740 of the used connector among those indicated at 1746 andthose indicated at 1748 is closed and the blood filter portion 1798disconnected by disconnecting the connectors 1743 of the filter 1715.However, the treatment fluid portion 1799 can remain in place.

Referring to FIG. 28, a peritoneal dialysis device is shown. One featureof the convenient design of the batch preparation and storage deviceembodiments of FIGS. 22 and 25 is that they permit convenient connectionto a variety of different kinds of treatment equipment. For example,instead of a full hemodialysis treatment and circuit as described withreference to FIG. 27, the batch preparation and storage device 1600 maybe employed with a peritoneal dialysis cycler, an embodiment of which isillustrated in FIG. 28. The fresh and spent dialysate lines 1832 and1833 may be connected to the batch preparation and storage device (anyembodiment) as, for example, the corresponding lines 1372 and 1362,respectively, of the embodiment of FIG. 19A. Pumps 1805 and 1806 may becontrolled by a controller 1810 using feedback control based on inletand outlet pressure sensor readings from pressure sensors 1820, 1825,1821 and 1826, respectively. In addition, precise inlet and outletpressure readings combined with a calibration curve for each pump mayallow the precise determination of total volume of fluid transferred toand from the patient. Using such a calibration curve approach may permitsuch a peritoneal dialysis cycler to use a compact unit using aperistaltic pump while providing high precision in metering dialysatefor treatment.

As is known, peritoneal dialysis can only be used up to a point in timeafter which the peritoneum cannot be used effectively for treatment.After this happens, patients must switch to normal dialysis, for exampleusing an extracorporeal treatment system. However, for many patients,peritoneal dialysis is preferred and such patients may wish to useperitoneal dialysis for a period of time, and later switch to normaldialysis. Another alternative is for patients to use both peritoneal andnormal dialysis at different times, giving them flexibility andpotentially extending the term over which the peritoneum can be used fortreatment. In such cases, as described below, convenient switchingbetween the types of treatment machines may be facilitated with a batchpreparation and storage device as described herein.

A peritoneal cycler according to the design of FIG. 28 (or otherdesigns) may be configured to rest on a table top. The design of thebatch preparation and storage device of FIG. 25 permits such aperitoneal cycler to be used until extracorporeal blood treatment isindicated at which point, the peritoneal cycler can be exchanged for anextracorporeal blood treatment device such as shown in FIG. 25. Nochange is required in the batch preparation and storage device 1600.

Note that the embodiments of FIGS. 19A through 19H, 19J, and 20 through28 are contemplated as being able to employ the data carrier and datacarrier reader devices, described above with reference to earlierfigures, for enforcing the expiration of replaceable components such asthe LTF modules, ST filter and fluid circuit modules, etc. of theforegoing embodiments or the treatment circuits. In addition, the samedata carrier devices may are contemplated for use in preventing re-useof previously used replaceable components.

The controller for the batch preparation storage and treatment devicesabove may provide a treatment scheduler that takes into account thepermitted storage term of the batch and the time the batch is created orproposed to be created. Such a scheduler may accept as inputs, the timesduring which the patient wishes to perform treatment and the schedulermay, in response, calculate and display the window of time during whichthe batch should be prepared for it to be ready during those treatmenttimes and still be available at the last treatment time. Thiscalculation may take into account the time it takes to prepare a batch,the length of time before the batch expires, estimates of how long ittakes a patient to set up a treatment and allowances for pausingtreatments and other information. Alternatively, the scheduler mayaccept a time when a batch is proposed to be prepared and then outputproposed treatment times, taking into account the type of treatment(daily or longer intervals), the intensity of treatment, size of batch,etc. The schedule may retain the schedule and make it available on awireless device, providing reminders, etc. for the various tasks to betimely performed according to entered schedules. In a preferredembodiment, the scheduler is provided by a server application accessiblethrough the web. The scheduler, may be a local application, a serverapplication, or split between a server and a thin client application(the client application running on the treatment controller). Theapplication may actually control the system to begin the preparation ofthe batch at a scheduled time. In the latter case, the batch containerand circuit may be pre-connected to the batch preparation and storagedevice and so that the system can then automatically start thepreparation at a scheduled time. Still further, if any problems areencountered, the scheduler system may alert the patient or otherresponsible person of the problem so that ameliorative actions may betaken.

Note that although in the above embodiments, the treatment regimenemphasized may have been daily treatment with moderate clearance, itshould be clear that the batch preparation and treatment device andother inventive embodiments described are consistent with othertreatment regimens.

Although the foregoing inventions have, for the purposes of clarity andunderstanding, been described in some detail by way of illustration andexample, it will be obvious that certain changes and modifications maybe practiced that will still fall within the scope of the appendedclaims. For example, the devices and methods of each embodiment can becombined with or used in any of the other embodiments. For anotherexample, the air vents described can be of any suitable description andneed not be membrane type air vents at all, although these arepreferred.

The invention claimed is:
 1. A medicament preparation and disposalsystem, comprising: a deionizing water filter containing a pretreatmentfilter, a UV module, and a resin module; a fluid circuit with aplurality of controllable valves configured to select a flow path anddirect a fluid received by the fluid circuit to a selected one of amedicament concentrate container, a batch container, a treatmentmachine, and a waste line having a conductivity sensor positioned alongthe waste line; the fluid circuit being selectively connectable toreceive medicament concentrate from the medicament concentrate containerand to receive the fluid from the batch container; the fluid circuitbeing selectively connectable to pump the fluid from the batch containerto the treatment machine; the fluid circuit being selectivelyconnectable to pump fluid from the batch container to the waste line andpast the conductivity sensor to thereby test a conductivity of the fluidfrom the batch container before conveying the fluid in the batchcontainer to the treatment machine; and the fluid circuit beingselectively connectable to pump fluid from the batch container to thewaste line to drain said batch container.
 2. The system of claim 1,further comprising a controller configured to control the fluid circuitwith the plurality of controllable valves.
 3. The system of claim 2,wherein the controller is configured to connect the batch container tothe waste line to empty when said controller detects that contents ofthe batch container are expired.
 4. The system of claim 1, wherein thefluid circuit includes four controllable valves and a pump.
 5. Thesystem of claim 1, wherein said batch container is connected to thefluid circuit by two fluid lines.
 6. The system of claim 5, wherein oneof said two fluid lines has a check valve with predefined crackingpressure.
 7. The system of claim 1, wherein the batch container has afluid warmer.
 8. The system of claim 6, wherein the cracking pressure isabout 3.5 pounds per square inch.
 9. The system of claim 6, wherein thefluid circuit includes a first pump configured to pump fluid through thefluid circuit, and said two fluid lines connecting the batch containerto the fluid circuit are linked by a pumping tube segment driven by asecond pump.
 10. A fluid preparation system, comprising: a disposablecomponent with preconnected tubing, the disposable component including asealed sterilized fluid circuit that includes a sealed sterilizedcontainer; a conductivity sensor preconnected to the container and incommunication with an interior of said container; at least one sealedconnector adapted for adding fluid to said container; and at least onesealed connector adapted for removing fluid from said container, whereinsaid conductivity sensor is contained in a test line that ispreconnected to the container, the test line being in communication withsaid interior and adapted to be connected to a source of suction therebyto draw a sample of contents of said container.
 11. A system as in claim10, wherein said test line includes a check valve to prevent ingress ofcontaminants into said container.
 12. A system as in claim 10, whereinsaid at least one sealed connector is adapted for adding fluid to saidcontainer and includes an inline sterile filter.
 13. A system as inclaim 12, further comprising: a controller; pumping actuators; clampscontrolled by the controller; and a deionization water purifier with aproduct water outlet having a connector for connection to said sterilefilter.
 14. The system of claim 13, wherein the fluid circuit includes aquantity of medicament concentrate.
 15. The system of claim 14, whereinsaid controller is programmed to pump said concentrate into saidsterilized container and to dilute the same using water from the productwater outlet.
 16. The system of claim 15, wherein the controller reads afluid quality sensor reading from said conductivity sensor and controlsa pump to continue or discontinue pumping responsively to said sensorreading.
 17. The system of claim 16, wherein said controller isprogrammed to maintain a clamp on a mixed fluid outlet of saidsterilized container responsively to said sensor reading.
 18. The systemof claim 14, wherein the controller reads a fluid quality sensor readingfrom said conductivity sensor and controls a pump to continue ordiscontinue pumping responsively to said sensor reading.
 19. The systemof claim 18, wherein said controller is programmed to maintain a clampon a mixed fluid outlet of said sterilized container responsively tosaid sensor reading.